On July 20, 2015 Heron Therapeutics, Inc. (NASDAQ:HRTX), a biotechnology company focused on improving the lives of patients by developing best-in-class medicines that address major unmet medical needs,reported that it has resubmitted its New Drug Application (NDA) for SUSTOL (granisetron) Injection, extended release, for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC) regimens, to the U.S. Food and Drug Administration (FDA) (Press release, Heron Therapeutics, JUL 20, 2015, View Source;p=RssLanding&cat=news&id=2068986 [SID:1234506539]).
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Heron expects confirmation of acceptance from the FDA and a Prescription Drug User Fee Act (PDUFA) goal date within the next few weeks. The Company anticipates a six-month review by the FDA.
The NDA filing includes data from the MAGIC study, Heron’s recently completed, multi-center, placebo-controlled, Phase 3 study in patients receiving HEC agents. The MAGIC study evaluated the efficacy and safety of SUSTOL as part of a three-drug regimen with the intravenous (IV) neurokinin-1 (NK1) receptor antagonist fosaprepitant and the IV/oral corticosteroid dexamethasone for the prevention of delayed nausea and vomiting in patients receiving HEC. The MAGIC study, which was conducted entirely in the U.S. using the 2011 ASCO (Free ASCO Whitepaper) guidelines for classification of emetogenic potential, is the only Phase 3 CINV study to-date to use the currently recommended, standard-of-care, three-drug regimen for CINV prophylaxis in a HEC population as the comparator: a 5-HT3 receptor antagonist, fosaprepitant and dexamethasone.
The MAGIC study’s primary endpoint was achieved. Specifically, the percentage of patients who achieved a Complete Response was significantly higher in the SUSTOL arm compared with the comparator arm (p=0.014). Significant benefit was also observed in the reduction in episodes of nausea, which has the greatest impact on patient quality of life. Data from a previous Phase 3 study of more than 1,300 patients, which was previously submitted to the FDA, demonstrated SUSTOL’s efficacy in the prevention of acute and delayed CINV associated with MEC regimens and acute CINV associated with HEC regimens.
"The rapid resubmission of the NDA for SUSTOL, the first and only 5-HT3 receptor antagonist with extended-release technology and 5-day CINV prevention in both MEC and HEC, is a major milestone for Heron Therapeutics," commented Barry D. Quart, Pharm.D., Chief Executive Officer of Heron. "We look forward to working closely with the FDA during the SUSTOL NDA review period, as we believe SUSTOL has the potential to improve the lives of patients suffering from CINV by significantly reducing both nausea and vomiting associated with MEC or HEC regimens."
About SUSTOL for Chemotherapy-Induced Nausea and Vomiting
SUSTOL (granisetron) Injection, extended release, which utilizes Heron’s proprietary Biochronomer drug delivery technology, is Heron’s novel, long-acting formulation of granisetron for the prevention of chemotherapy-induced nausea and vomiting (CINV). Granisetron, an FDA-approved 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist was selected due to its broad use by physicians based on a well-established record of safety and efficacy. SUSTOL has been shown to maintain therapeutic drug levels of granisetron for five days with a single subcutaneous injection. SUSTOL is being developed for the prevention of both acute (day 1 following the administration of chemotherapy agents) and delayed (days 2-5 following the administration of chemotherapy agents) CINV associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC). While other 5-HT3 antagonists are approved for the prevention of CINV, SUSTOL is the first agent in the class to demonstrate efficacy in reducing the incidence of delayed CINV in patients receiving HEC, a major unmet medical need, in a randomized Phase 3 study.
Affecting 70-80% of patients undergoing chemotherapy, CINV is one of the most debilitating side effects of such treatments, often attributed as a leading cause of premature discontinuation of cancer treatment. 5-HT3 receptor antagonists have been shown to be among the most effective and preferred treatments for CINV. However, an unmet medical need exists for patients suffering from CINV during the delayed phase, which occurs on days 2-5 following the administration of chemotherapy agents. Only one 5-HT3 receptor antagonist is approved for the prevention of delayed CINV associated with MEC, and no 5-HT3 receptor antagonists are approved for prevention of delayed CINV associated with HEC.
SUSTOL was the subject of a recently completed, multi-center, placebo-controlled, Phase 3 clinical study in patients receiving HEC regimens known as MAGIC. The MAGIC study evaluated the efficacy and safety of SUSTOL as part of a three-drug regimen with the intravenous (IV) neurokinin-1 (NK1) receptor antagonist fosaprepitant and the IV/oral corticosteroid dexamethasone. The MAGIC study, which was conducted entirely in the U.S. using the 2011 ASCO (Free ASCO Whitepaper) guidelines for classification of emetogenic potential, is the only Phase 3 CINV prophylaxis study in a HEC population performed to date to use the currently recommended, standard-of-care, three-drug regimen as a comparator: a 5-HT3 receptor antagonist, fosaprepitant, and dexamethasone. The study’s primary endpoint was achieved. Specifically, the percentage of patients who achieved a Complete Response in the delayed phase was significantly higher in the SUSTOL arm compared with the comparator arm (p=0.014). Heron resubmitted its New Drug Application (NDA) for SUSTOL to the U.S. Food and Drug Administration (FDA) in July 2015. SUSTOL is not approved by the FDA or any other regulatory authority.